NCT02158481已完成不适用
Investigating the Effects of Dietary Ingredients on Vascular Function During Acute Glucose Load
Unilever R&D1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Interleukin-6 (IL-6) levels.
研究概览
简要总结
The main aim of the study is to investigate the effects of dietary ingredients (polyphenols and carotenoids) on vascular function during acute glucose load. Each subject will receive 4 weeks of intervention with test product or placebo product after a dietary restriction run-in period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT) immediately after the run-in phase and at the end of the intervention phase. During the OGTT, blood samples will be taken at regular intervals.
The study will be conducted in subjects with impaired glucose tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females confirmed with IGT;
- •Age ≥ 35 and ≤ 65 year at screening;
- •Body Mass Index (BMI) > 25 and <40 kg/m2;
- •Reported intense sporting activities ≤ 10h/w;
- •Reported alcohol consumption ≤ 14 units/week (female volunteers) or ≤ 21 units/week (male volunteers)
- •Currently not smoking and being a non-smoker for at least six months
排除标准
- •Any medical condition or use of over-the-counter and prescribed medication which might affect study measurement (judged by the study physician);
- •No reported participation in another nutritional or biomedical trial 3 months before screening;
- •Reported weight loss or gain of 10% or more during a period of 6 months prior to screening;
- •Anti-hyperglycemic drug or other medication which interferes with study measurements;
- •No blood donation 1 month prior to screening;
- •Reported allergy or intolerance to test products or other food products provided during the study;
结局指标
主要结局
Interleukin-6 (IL-6) levels.
时间窗: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
次要结局
- Pro-inflammatory and oxidative stress biomarkers(At baseline (after 2 weeks run-in period) and after 4 weeks intervention)
- Cell stress-defence responses(At baseline (after 2 weeks run-in period) and after 4 weeks intervention)
- Clinical chemistry parameters(At baseline (after run-in period of 2 weeks) and after 4 weeks intervention)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
Unknown
The study focuses on the hospital-based local formulation of dairy legume-based therapeutic food as a strategy for managing severe acute malnutrition among children aged 6 to 59 months.Nutritional, Metabolic, EndocrinePACTR202309487179676Tamimu Yakubu140
已完成
不适用
A study of the effect of the food ingredients on muscle strength in human lower limb.JPRN-UMIN000029735Suntory MONOZUKURI Expert Limited140
已完成
1 期
Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer CachexiaWeight LossGastrointestinal CancerLung CancerCancer CachexiaNCT04131426University of Rochester25
已完成
不适用
An Exploratory Investigation of Dietary Supplementation and Its EffectQuality of LifeNCT05037877HUM Nutrition, Inc.110
已完成
不适用
Canola Oil, Fibre and DHA Enhanced Clinical TrialMetabolic SyndromeNCT02091583University of Manitoba30